Double-blind, placebo-controlled evaluation of biorest liposomal alendronate in diabetic patients undergoing PCI: The BLADE-PCI trial.

Alendronate Coronary Angiography / methods Coronary Artery Disease / complications Diabetes Mellitus Drug-Eluting Stents Humans Neointima / etiology Percutaneous Coronary Intervention / methods Tomography, Optical Coherence Treatment Outcome

Journal

American heart journal

ISSN: 1097-6744

Titre abrégé: Am Heart J

Pays: United States

ID NLM: 0370465

Informations de publication

Date de publication:
07 2022

Historique:

received: 21 01 2021

revised: 07 03 2022

accepted: 08 03 2022

pubmed: 21 3 2022

medline: 31 5 2022

entrez: 20 3 2022

Statut: ppublish

Résumé

Diabetes mellitus (DM) is an important predictor of neointimal hyperplasia (NIH) and adverse clinical outcomes after percutaneous coronary intervention (PCI). LABR-312, a novel intravenous formulation of liposomal alendronate, has been shown in animal models to decrease NIH at vascular injury sites and around stent struts. The aim of the Biorest Liposomal Alendronate Administration for Diabetic Patients Undergoing Drug-Eluting Stent Percutaneous Coronary Intervention trial was to assess the safety, effectiveness, and dose response of LABR-312 administered intravenously at the time of PCI withDES in reducing NIH as measured by optical coherence tomography postprocedure in patients with DM. Patients with DM were randomized to a bolus infusion of LABR-312 vs placebo at the time of PCI. Dose escalation of LABR-312 in the study arm was given: 0.01 mg, 0.03 mg, and 0.08 mg. The primary endpoint was the in-stent %NIH volume at 9 months as measured by optical coherence tomography. From September 2016 to December 2017, 271 patients with DM undergoing PCI were enrolled; 136 patients were randomized to LABR-312 infusion and 135 patients were randomized to placebo. At 9-month follow-up, no difference was seen in the primary endpoint of %NIH between LABR-312 and placebo (13.3% ± 9.2 vs 14.6% ± 8.5, P = .35). No differences were present with the varying LABR-312 doses. Clinical outcomes at 9 months were similar between groups. Among patients with DM undergoing PCI with drug-eluting stents, a bolus of LABR-312 injected systematically at the time of intervention did not result in a lower rate in-stent %NIH volume at 9-month follow-up.

Sections du résumé

BACKGROUND

METHODS

Patients with DM were randomized to a bolus infusion of LABR-312 vs placebo at the time of PCI. Dose escalation of LABR-312 in the study arm was given: 0.01 mg, 0.03 mg, and 0.08 mg. The primary endpoint was the in-stent %NIH volume at 9 months as measured by optical coherence tomography.

RESULTS

From September 2016 to December 2017, 271 patients with DM undergoing PCI were enrolled; 136 patients were randomized to LABR-312 infusion and 135 patients were randomized to placebo. At 9-month follow-up, no difference was seen in the primary endpoint of %NIH between LABR-312 and placebo (13.3% ± 9.2 vs 14.6% ± 8.5, P = .35). No differences were present with the varying LABR-312 doses. Clinical outcomes at 9 months were similar between groups.

CONCLUSIONS

Among patients with DM undergoing PCI with drug-eluting stents, a bolus of LABR-312 injected systematically at the time of intervention did not result in a lower rate in-stent %NIH volume at 9-month follow-up.

Identifiants

DOI: 10.1016/j.ahj.2022.03.004 PMID: 35305955

pubmed: 35305955

pii: S0002-8703(22)00052-7

doi: 10.1016/j.ahj.2022.03.004

pii:

doi:

Substances chimiques

Alendronate X1J18R4W8P

Banques de données

ClinicalTrials.gov

['NCT02645799']

Types de publication

Journal Article Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

Pagination

45-56